(308 days)
A patient interface, face mask, for use with CPAP and bi-level systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). Single use only < 24 hours.
The proposed patient interface face mask incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use. Adhesive foam to seal to the patient face. One size - medium. Models with and without Integral fixed leak (exhalation) port.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, categorized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criterion (Predicate Device Performance) | Reported Device Performance (ARCimed CPAP mask) |
|---|---|---|
| Exhaust Flow Range | Pressure / Flow (lpm)3 cm H2O / 17.8 lpm10 cm H2O / 31.5 lpm20 cm H2O / 42.6 lpm30 cm H2O / 51.7 lpm40 cm H2O / 60.1 lpm(Based on ResMed Quattro K063122) | Pressure / Flow (lpm)3 cm H2O / 19.9 lpm10 cm H2O / 33.3 lpm20 cm H2O / 47.1 lpm30 cm H2O / 58.0 lpm40 cm H2O / 67.8 lpmPass / fail +/- 15% (Implied acceptance within this range of predicate) |
| Pressure Drop (Resistance to Flow) | ResMed – K0631220.59 cm H2O @ 50 lpm1.2 cm H2O @ 100 lpm | 0.35 cm H2O @ 50 lpm0.81 cm H2O @ 100 lpm |
| CO2 Rebreathing | ResMed – K0631220.25% EtCO2 (Measured change from baseline) | 0.06% EtCO2 (Measured change from baseline) |
| Adhesive Seal | Advanced Warming – K950771Offers a tight sealNo performance requirements other than it will remain attached to patient's face | We are claiming no performance requirements other than the mask will seal and remain attached to the patient's face. |
| Vented/Non-vented models (Anti-Asphyxia Valve compatibility) | Yes – ResMed – K063122Offer a mask with optional anti-asphyxia valve | Vented and Non-vented models requires attachment to a circuit with anti-asphyxia valve incorporated demonstrated to activate AAV valve equivalent to predicates. Should be used with AAV with minimum opening pressures of < 3 cm H2O. |
| Dead Space | 203 ml (K063122) | 91 ml |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The data presented appears to be laboratory or bench testing results rather than clinical study data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the involvement of experts for establishing ground truth for the test set. The reported device performance metrics (exhaust flow, pressure drop, CO2 rebreathing, dead space) are objective physical measurements, likely derived from engineering or laboratory testing. The statement regarding the adhesive seal ("will seal and remain attached to the patient's face") is a functional claim, not an expert-derived ground truth.
4. Adjudication Method for the Test Set
As there's no mention of expert involvement or interpretation for the test set, no adjudication method (e.g., 2+1, 3+1) is described or implied. The data seems to be from direct measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document describes a comparison of device specifications and performance metrics against predicate devices, not an MRMC study. There is no information about human readers or improvement with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a physical CPAP mask, not an algorithm or AI-powered system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance described is the standalone performance of the physical mask.
7. The Type of Ground Truth Used
The ground truth for the performance metrics appears to be objective physical measurements and engineering specifications derived from testing the device itself, and comparison against the established specifications of predicate devices. For example:
- Exhaust flow: Measured directly.
- Pressure Drop: Measured directly.
- CO2 Rebreathing: Measured directly (percentage EtCO2 change from baseline).
- Dead Space: Measured directly.
- Adhesive Seal: Functional claim, likely verified through physical testing for adherence.
There is no mention of expert consensus, pathology, or outcomes data as ground truth.
8. The Sample Size for the Training Set
Not Applicable. The device is a physical CPAP mask. There is no AI model or algorithm that requires a "training set" in the context of this submission. The comparison is based on physical and functional equivalence to predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set mentioned or implied for this physical device, there is no ground truth established for a training set.
{0}------------------------------------------------
K071915 Page 1 of 3
MAY 1 4 2008
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 3 7-May-08
| ARCimed Laboratories, LLC85 Oak StreetWeston, MA 02493 | Tel - 781-237-4544 |
|---|---|
| Official Contact: | Robert W. Daly, Managing Member |
| Proprietary or Trade Name: | ARCimed CPAP mask |
| Common/Usual Name: | Patient interface for use with CPAP systems |
| Classification Name: | Ventilator, non-continuous (respirator), accessoryBZD - 868.5905 |
| Device: | ARCimed CPAP mask |
| Predicate Devices: | ResMed - Quattro Full Face Mask - K063122Advanced Warming - Adhesive mask - K950771Respironics Full face mask - K002465 |
Device Description:
The proposed patient interface face mask incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- Adhesive foam to seal to the patient face .
- . One size - medium
- Models with and without Integral fixed leak (exhalation) port .
| Indications for Use: | A patient interface, face mask, for use with CPAP and bi-level systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). | |
|---|---|---|
| Single use only < 24 hours. | ||
| Patient Population: | Adults (>30 kg) with OSA | |
| Environment of Use: | Hospitals, Home, sub-acute care settings |
{1}------------------------------------------------
K071915 Page 2 of 3
Non-Confidential Summary of Safety and Effectiveness
Comparative table:
| Features | Predicates | Proposed Device |
|---|---|---|
| ResMed QuattroFull Face Mask - K063122Advanced Warming -Adhesive Mask - K950771Respironics Full face mask –K002465 | ARCimed CPAP mask | |
| Indications for use | A patient interface for use withCPAP and bi-level systems usedin the treatment of adult (> 30kg) OSA and / or ventilatorysupport.Anesthesia face mask withadhesive seal (AdvancedWarming - K950771) | A patient interface for use withCPAP and bi-level systems used inthe treatment of adult (>30 kg) OSAand / or ventilatory support. |
| Environment ofUse | Home, Hospital, Sub-acuteInstitutions | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Disposable, singlepatient use | No – multi-use – K063122Yes – K950771 | Yes |
| Components | ShellCushionAdhesive seal (K950771) | ShellFoamAdhesive seal |
| Dead space | 203 ml (K063122) | 91 ml |
| Fixed leak port | ResMed Quattro K063122 | |
| Exhaust Flowrange | Pressure / Flow (lpm)3 cm H2O / 17.8 lpm10 cm H2O / 31.5 lpm20 cm H2O / 42.6 lpm30 cm H2O / 51.7 lpm40 cm H2O / 60.1 lpm | Pressure / Flow (lpm)3 cm H2O / 19.9 lpm10 cm H2O / 33.3 lpm20 cm H2O / 47.1 lpm30 cm H2O / 58.0 lpm40 cm H2O / 67.8 lpmPass / fail +/- 15% |
{2}------------------------------------------------
K071915 Page 3 of 3
Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 7-May-08
| Features | Predicates | Proposed Device |
|---|---|---|
| ResMed QuattroFull Face Mask - K063122Advanced Warming –Adhesive Mask - K950771Respironics Full face mask –K002465 | ARCimed CPAP mask | |
| Vented andNon-vented stylesrequires anti-asphyxia valve inthe circuit | Yes – ResMed – K063122Offer a mask with optional anti-asphyxia valve | Vented and Non-vented modelsrequires attachment to a circuit withanti-asphyxia valve incorporateddemonstrated to activate AAV valveequivalent to predicatesShould be used with AAV withminimum opening pressures of < 3 cm H2O |
| Pressure Drop(Resistance toflow) | ResMed – K0631220.59 cm H2O @ 50 lpm1.2 cm H2O @ 100 lpm | 0.35 cm H2O @ 50 lpm0.81 cm H2O @ 100 lpm |
| CO2 rebreathingMeasured changefrom baseline | ResMed – K0631220.25% EtCO2 | 0.06% EtCO2 |
| Adhesive as a seal | Advanced Warming – K950771Offers a tight sealNo performance requirementsother have will remain attachedto patient's face | We are claiming no performancerequirements other than the maskwill seal and remain attached to thepatient's face. |
Differences Between Other Legally Marketed Predicate Devices:
The proposed device is viewed as substantially equivalent to the predicate devices, K950771, K002465, and K063122.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with flowing lines, representing the department's mission related to health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
ARCimed Laboratories LLC C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
Re: K071915
Trade/Device Name: ARCimed CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 8, 2008 Received: May 9, 2008
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{4}------------------------------------------------
Page 2 - Mr. Dryden
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use Statement
Page 1 of 1
510(k) Number: K071915 (To be assigned)
Device Name: ARCimed CPAP mask
Indications for Use: A patient interface, face mask, for use with CPAP and bilevel systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port).
Single use only < 24 hours.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K671915
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).